In the absence of consent

Modern clinical practice and research are built upon the ethical foundation of voluntary informed consent. Especially in the world of clinical research, we are compelled to navigate a complex maze of rule and regulation in this respect, and for very good reason.

Much of the legislation and professional regulation that govern the issue of consent in research unfortunately has its origins in tales of atrocity, abuse and exploitation. All histories of clinical research re-tell the tales of ancient, and not so ancient, experimentation where ruthless investigators probed, incised and manipulated their hapless victims without a thought for their well-being.

While this is true and should never be forgotten, it is far from the whole story. And if we are to have a rounded view of where we have come from, and if we are to understand the meaning of our modern research governance, it is important that we look beyond these stereotypes.

It is uncommon to find any mention of consent or a consent process in research involving human participants before the turn of the 20th century. However, prior to that time there are many well-documented examples of experimentation involving interventions, including many that were potentially life-threatening. Without the mention of consent in these tales, we are instantly on our guard and may condemn these experiments as immediately unlawful and immoral. But, even if there is no formal informed consent process, at least as we would recognise it today, the alternative is not merely abuse and exploitation. There is surely a lot of middle ground and much of it might still be governed by common decency, professionalism and basic human respect. Our forebears in clinical research were not, as they are sometimes depicted, all monsters. In fact, almost none of them were—they just lived in a different time.

The approach they took when working in a world where the very notion of patient consent was quite alien, may still have been respectful. Take the example of the following case study.

Edward Jenner, the Gloucestershire doctor from the 18th century, is today best remembered for his contribution to our understanding of vaccination. In the spring of 1796, he performed his first human experiments. A local milkmaid called Sarah Nelms had contracted cow pox and Jenner found her to have fresh lesions on her hands. On 14 May 1796, Jenner took pus from Nelms’ lesions, and inoculated the son of his gardener. The boy, James Phipps, was 8-years old at the time, and he subsequently developed a mild fever and discomfort in the axillae, but apart from these minor symptoms quickly recovered. Almost seven weeks after the cow pox inoculation, Jenner inoculated the boy again, this time with pus from a fresh smallpox lesion. Phipps, despite this challenge, did not develop the disease and Jenner concluded that he was immune. This clinical experiment along with others were written up by Jenner who detailed the procedures but not the informed consent process for there was none.

There is no record that James Phipps resented his involvement in Jenner’s clinical experiments. Indeed, the fact that he served as one of Jenner’s pall-bearers some 27 years later at the doctor’s funeral would add weight to the belief that he bore Jenner no ill will as he reflected on his childhood involvement in the vaccination experiments. Jenner’s experiments would, of course, never find approval from a modern research ethics committee, and his inclusion of minors without any formal parental consent would provoke outrage if carried out today. But, that does not mean he did not respect Phipps and his family.

Of course, we might say that Phipps, as the son of Jenner’s gardener, was outclassed and that his parents were in no position to refuse their employer. All of this is true, but again it does not automatically make Jenner a villain. You may also say that this is a poor example because Phipps was ultimately unharmed by Jenner. Might we not cite the countless other examples of individuals who were maimed in other clinical experiments, who died as a result of their involvement or lived on feeling embittered and used? Almost certainly we could, but the point of this argument is not to deny that there has been incalculable harm done to people without their knowledge and consent in the name of medical research. It is to argue that it is not universally true that all past investigators did not care or treat their subjects with respect.

It is also about the importance of not measuring the past against the standards of the present. I wonder how we will fare when it is our turn to be judged by history. In the 22nd and 23rd centuries, what will medical historians think of our current practices and what we chose to concern us? Will we be ridiculed for our lack of sophistication, pitied for our ignorance or even vilified for our cruelty? Will we be viewed as morally reprehensible as well as stupid? Or will an enlightened historian in the future say that we were doing the best we could with what we had and with what we knew? With luck, he or she might conclude that we were not fools, nor were we barbarians or monsters; we were just the products of our time.

Coming Soon…

Now available in paperback…

Testing the Waters: Lessons from the History of Drug Research

What can we learn from the past that may be relevant to modern drug research?

“I cannot recommend it highly enough: even if you read nothing else about the origins of drug research and what it can (should?) teach us, read this….This is a ‘buy’.” Madhu Davis review in Pharmaceutical Physician May 2016.

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One thought on “In the absence of consent”

Thanks Allan – so true. As with clinical practice we must recognise how behaviours and attitudes have changed over time, and that, while we do things differently now, it does not imply malicious intent.